Description
Etonogestrel implant is used in women to prevent pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.
This medicine will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is to be given only by or under the direct supervision of your doctor.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies on the relationship of age to the effects of etonogestrel implant have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.
Geriatric
Appropriate studies on the relationship of age to the effects of etonogestrel implant have not been performed in geriatric patients. This medicine is not indicated for use in elderly women.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Dasabuvir
- Fezolinetant
- Ombitasvir
- Paritaprevir
- Ritonavir
- Tranexamic Acid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amobarbital
- Amprenavir
- Apalutamide
- Aprepitant
- Armodafinil
- Artemether
- Belzutifan
- Bexarotene
- Boceprevir
- Bosentan
- Butabarbital
- Butalbital
- Carbamazepine
- Cenobamate
- Clobazam
- Dabrafenib
- Darunavir
- Dexamethasone
- Dipyrone
- Elafibranor
- Elagolix
- Elvitegravir
- Enasidenib
- Encorafenib
- Enzalutamide
- Eslicarbazepine Acetate
- Etravirine
- Felbamate
- Fluconazole
- Fosamprenavir
- Fosaprepitant
- Fosphenytoin
- Glecaprevir
- Grazoprevir
- Griseofulvin
- Indinavir
- Isotretinoin
- Itraconazole
- Ivosidenib
- Ketoconazole
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Atazanavir
- Efavirenz
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Tobacco
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding (non-menstrual) or
- Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
- Breast cancer, known or suspected, or progestin-sensitive, or history of or
- Heart attack, or history of or
- Liver disease (active), including tumors or
- Stroke, or history of—Should not be used in patients with these conditions.
- Depression, or history of or
- Diabetes or
- Fluid retention (body swelling) or
- Gallbladder disease or
- Heart disease or
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Hypertension (high blood pressure) or
- Kidney disease—Use with caution. May make these conditions worse.
- Obesity—This condition may cause the medicine to not work as well.
Proper Use
Nexplanon® is an implant that is surgically placed and removed under the skin of the upper arm by a trained healthcare provider. The implant is placed in the upper arm for 3 years and then removed by the end of the third year.
It is very important that you tell your doctor if you think you might be pregnant or if you missed a period before you receive this medicine. A pregnancy test will be done to make sure you are not pregnant before this medicine is inserted.
This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
The implant is usually inserted by your doctor within the first 5 days of your menstrual period.
After this medicine is inserted, your doctor should feel your arm to check that the implant is in the right place. You can also check it by gently pressing your fingertips over the insertion site. You should be able to feel the small rod. If you cannot feel the implant in your arm, you will need to use a non-hormonal birth control (such as condoms, spermicide) until your doctor confirms that the implant is in place.
Your doctor will treat the arm with numbing medicine and insert the implant with a special tool. The incision will be covered with 2 bandages. You may remove the top bandage after 24 hours. Keep the smaller bandage clean and dry and in place for 3 to 5 days.
Your doctor must remove this medicine after 3 years. If you would like to stop using this medicine, your doctor can remove it at any time. Do not try to remove the implant by yourself.
If you still want to prevent pregnancy after this medicine is removed, you should start using another form of birth control (eg, condoms, diaphragms, or spermicides) right away. If you still want to continue using this medicine, your doctor can insert a new implant under your skin after taking the old one out.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects.
Tell your doctor if you have recently given birth. You may start using this medicine 4 weeks after giving birth.
Etonogestrel implant will not protect you from getting HIV/AIDS or other sexually transmitted diseases. Tell your doctor if you or your partner begins to have sexual intercourse with other people, or you or your partner tests positive for a sexually transmitted disease. If this is a concern for you, talk with your doctor.
Tell your doctor if you had an allergic reaction to numbing medicines (anesthetics) or skin cleansers (antiseptics). These medicines will be used when the etonogestrel implant is inserted into your arm.
This medicine may cause several problems related to insertion and removal, including pain, irritation, swelling, bruising, scarring, or other complications. Talk to your doctor about these possible risks.
Etonogestrel implant may break or bend while it is in your arm due to external forces (eg, manipulation of the implant or contact sports). A broken implant may move from the insertion site. Call your doctor if you feel that the implant may have broken or bent while in your arm.
You could have less bleeding or may even stop having periods while using this medicine. Call your doctor if you have a change from your regular bleeding pattern after you have had your implant for awhile, such as more bleeding or if you miss a period (and if you were having periods even with your implant).
Call your doctor right away if you think you have become pregnant while you are using this medicine. You may have a higher risk of an ectopic pregnancy (occurs outside the womb) if you get pregnant while your implant is in place. This can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.
Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, a sudden loss of coordination, or vision changes while using this medicine.
This medicine may also increase your risk of having ovarian cysts, breast cancer, gallbladder problems, or liver tumors. Talk to your doctor if you have any concerns.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.
This medicine may also increase the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.
If you wear contact lenses and you have blurred vision, difficulty in reading, or any other change in vision while using this medicine, check with your doctor right away. Your doctor may want your eyes be checked by an eye doctor (ophthalmologist).
Before you have any medical tests, tell the medical doctor in charge that you are using etonogestrel implant. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Breast pain
- chills
- cough
- diarrhea
- fever
- general feeling of discomfort or illness
- headache
- joint pain
- loss of appetite
- muscle aches and pain
- nausea
- runny nose
- shivering
- sore throat
- sweating
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Less common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the insertion site
- bloating
- blurred vision or other changes in vision
- breast discharge
- breast enlargement
- burning feeling while urinating
- chest tightness
- difficult or painful urination
- difficulty with breathing
- difficulty with swallowing
- dizziness
- headache, severe and throbbing
- lumps in the breasts
- nervousness
- noisy breathing
- painful or tender cysts in the breasts
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash, hives, itching
- slow or fast heartbeat
- stomach or pelvic discomfort, aching, or heaviness
- swelling of the hands, ankles, feet, or lower legs
Rare
- Collection of blood under the skin at the insertion site
- deep, dark purple bruise at the insertion site
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- blemishes on the skin, pimples
- body aches or pain
- crying
- depersonalization
- discouragement
- dysphoria
- ear congestion
- euphoria
- feeling sad or empty
- hoarseness
- increased clear or white vaginal discharge
- increased weight
- irregular bleeding cycle
- irritability
- itching of the vagina or genital area
- light vaginal bleeding between regular menstrual periods
- loss of interest or pleasure
- loss of voice
- mental depression
- nasal congestion
- pain, cramps, or heavy menstrual bleeding
- pain during sexual intercourse
- pain or tenderness around the eyes and cheekbones
- paranoia
- quick to react or overreact emotionally
- rapidly changing moods
- stomach pain
- tender, swollen glands in the neck
- thick, white vaginal discharge with no odor or with a mild odor
- trouble concentrating
- voice changes
Less common
- Abnormal ejaculation
- abnormal or decreased touch sensation
- belching
- bone pain
- burning feeling in the chest or stomach
- decreased interest in sexual intercourse
- difficulty having a bowel movement
- difficulty with moving
- dull ache or feeling of pressure or heaviness in the legs
- excess air or gas in the stomach or intestines
- feeling of vaginal pressure
- feeling of warmth
- hair loss or thinning of the hair
- heartburn
- inability to have or keep an erection
- increased appetite
- increased hair growth on the forehead, back, arms, and legs
- indigestion
- itching skin near damaged veins
- lack or loss of strength
- loss in sexual ability, desire, drive, or performance
- muscle cramping or stiffness
- passing gas
- pelvic pain
- redness of the face, neck, arms, and occasionally upper chest
- redness, swelling in the ear, or earache
- sleepiness or unusual drowsiness
- sneezing
- stomach bloating and cramping
- stuffy nose
- swollen joints
- tenderness in the stomach area
- vaginal burning or pain
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
